The World Health Organization (WHO) has granted emergency use authorization to a COVID-19 vaccine manufactured by the Chinese state-owned company Sinopharm.
The Sinopharm is the first vaccine developed by a non-Western country to get WHO backing. The approval paves the path for Sinopharm’s offering to be included in the UN-backed COVAX program in coming weeks or months which is distributed through UNICEF and the WHO’s Americas regional office.
The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG). Aside from efficacy numbers, the Chinese manufacturer has released very little public data about its two vaccines, one is Sinopharm and the other developed by the Wuhan Institute of Biological Products.
“This afternoon, WHO gave an emergency use listing to sign off on Beijing’s COVID-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality,” WHO Director-General Tedros Adhahom Ghebreysus stated.
The Sinopharm vaccine will join ones made by Pfizer-BioNTech, Johnson & Johnson, Moderna, AstraZeneca, and a version of the AstraZeneca vaccine made by the Serum Institute of India, in receiving the coveted authorization from the UN health agency.
Significance of WHO approval
The announcement raised the prospect that the Chinese vaccine, which has already been exported by millions of doses in some countries, could join the UN’s arsenal against COVID-19 at a time when supplies of other Western-made or -developed vaccines have been deficient.
“The addition of (the Sinopharm) vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr. Mariangela Simao, WHO assistant director-general for access to health products.
Gavi, the Vaccine Alliance, which co-runs COVAX, welcomed the announcement. Sinopharm can now be included in the COVAX program, which provides equitable access to vaccines against COVID-19, paving the way for millions of doses to reach needy countries.
Before the WHO approval, the Sinopharm vaccine was already being widely used, with an estimated 65 million doses administered, according to reports. In addition to China, countries already using the vaccine include the UAE, Pakistan and Hungary.
The decision to approve the vaccine for emergency use was made by the WHO’s technical advisory group, which reviewed the clinical data and manufacturing practices and concluded that the vaccine’s efficacy for symptomatic and hospitalized cases of COVID-19 was expected to be 79 percent.
Sinopharm hasn’t released its late-stage test results in scientific journals, so the WHO requested a breakdown of its data, which came mostly from the UAE.
A study conducted in Abu Dhabi, where the vaccine has accounted for the bulk of COVID-19 shots administered since the start of the mass vaccination campaign, found it was 100 percent effective against death.
The study also reveals that the vaccine is 93 percent effective in preventing hospitalization and 95 percent effective against admission to intensive care. According to Sinopharm, its overall efficacy is 79 percent.
Earlier, a separate group advising WHO on vaccines said it was confident the Sinopharm protects people between 18-59 age. But it showed low levels of confidence in the vaccine’s efficacy for people 60 and over.
″We came to the conclusion that there is enough evidence of safety and the capacity of the vaccine to prevent severe disease or symptomatic and hospitalized cases up to 79 percent. The information we have for people over 60 is still very scarce,” said Dr. Alejandro Cravioto, who heads the WHO advisory group on immunizations.